Baclofen
NDC Package 17856-1024-1

11-digit billing NDC: 17856102401
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Baclofen is tablets, USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function.Baclofen tablets, USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases.Baclofen tablets, USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.The efficacy of baclofen tablets, USP in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions. Marketed by Atlantic Biologicals Corps, this product is identified by NDC 17856-1024 and is authorized under FDA application ANDA074584.

Identification & Billing

NDC Package Code
17856-1024-1
Package Description
100 POUCH in 1 CASE / 1 TABLET in 1 POUCH
Product Code
17856-1024
11-Digit Billing Format
17856102401
RxNorm Crosswalk
RxCUI: 197391 - baclofen 10 MG Oral Tablet

Clinical Specifications

Proprietary Name
Baclofen
Dosage Form
-
Usage Information
Baclofen tablets, USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function.Baclofen tablets, USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases.Baclofen tablets, USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.The efficacy of baclofen tablets, USP in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.

Regulatory & Marketing

Labeler Name
Atlantic Biologicals Corps
FDA Application #
ANDA074584
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-20-2010
Listing Expiration
12-31-2018
Exclude Flag
I
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 17856-1024-1 identifies a specific commercial package of 100 pouch in 1 case / 1 tablet in 1 pouch of Baclofen, labeled by Atlantic Biologicals Corps. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Atlantic Biologicals Corps on October 20, 2010. The current certification is valid through December 31, 2018.

How is this Atlantic Biologicals Corps product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17856102401. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
17856-1024-1
11-Digit CMS (5-4-2)
17856-1024-01

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.